Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea

Sickle Cell Anemia Clinical Trial

Official title:

Long Term Follow up in Sickle Cell Patients Treated by Hydroxyurea.Observational Retrospective Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480974
• Other study ID #: 5321006.EMC
• Status: Completed
• Phase: N/A
• First received: May 31, 2007
• Last updated: September 3, 2009
• Start date: May 2007
• Est. completion date: December 2008

Study information

• Verified date: September 2009
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

Description:

Hydroxyurea was found to be a good treatment in adult patients with sickle cell anemia with significant decrease in the frequency of vaso-occlusive crises and other crises related to SCA. Several studies were published with relative short term follow up in pediatric and young adult age. The purpose of this study is to assess the long term follow up in a group of patients that initiated Hydroxyurea treatment in childhood.

A long term follow up will be recorded in a cohort of twenty SCA patients treated by Hydroxyurea for a period between 5 to 12 years. The frequency of vaso-occlusive crises, acute chest syndrome, blood transfusions, and hospitalization will be recorded retrospectively. Also the mean hgb level and hgb F percentage will be summarized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 40 Years

Eligibility

Inclusion Criteria:

• All patients treated by Hydroxyurea in the Pediatric Hematology Unit.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Anemia
• Sickle Cell Thalassemia
• Thalassemia

Intervention

Other:
• Clinical follow up and laboratory analysis
Clinical follow up and laboratory analysis

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,